Bio-Thera Announces Positive Results from Phase 3 Trial of Ustekinumab Biosimilar BAT2206

Min Zheng
Credit: International Psoriasis Council

An announcement from Bio-Thera Solutions suggests an additional ustekinumab biosimilar could be on the horizon.

The company’s fourth proposed biosimilar to achieve positive results in phase 3 trials, the announcement of positive results for BAT2206, a biosimilar to ustekinumab, come 2 years after Bio-Thera entered into a commercialization and license agreement with Hikma for BAT2206 in August 2021.¹

"I'm very pleased to have participated in the successful global Phase 3 study of BAT2206," said study investigator Min Zheng, a professor in the Department of Dermatology at Zhejiang University School of Medicine.¹ "BAT2206 will provide a new affordable treatment option for global patients in need.”

An interleukin-12 and -23 antagonist, ustekinumab (Stelara) has been a staple in treatment algorithms dating back more than a decade to the agent’s 2009 approval for the treatment of psoriasis. Since 2009, the agent has seen its list of indications expand from psoriasis to include psoriatic arthritis, severe plaque psoriasis, Crohn disease, and more, with the agent scoring a pair of approvals in pediatric patients in 2020 and 2022.²

The news of positive results from BAT2206 in a phase 3 trial come just more than a month after ustekinumab-auub (Wezlana) became the first biosimilar to ustekinumab to receive approval from the FDA.³ A global, multicenter, randomized, double-blind, parallel arm trial, the phase 3 study was designed to compare the efficacy, safety, immunogenicity, and pharmacokinetics of BAT2206 relative to ustekinumab in patients with moderate to severe plaque psoriasis.¹

With a total patient population of 556 patients, results of the trial’s primary endpoint of improvement from baseline in Psoriasis Area and Severity Index score to week 12 demonstrated the effects of BAT2206 were highly similar with ustekinumab. According to Bio-Thera, results of the study will be presented in a future medical meeting or publication.¹

"We are pleased to report on our fourth proposed biosimilar with positive Phase 3 study results. These results demonstrate the potential of our proposed ustekinumab biosimilar to be a safe and effective treatment," said Shengfeng Li, PhD, chief executive officer at Bio-Thera Solutions.¹ "Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars."

References:

1. Bio-Thera Solutions. Bio-thera solutions announces positive results from phase 3 study of BAT2206, a proposed biosimilar referencing Stelara®. BioSpace. November 29, 2023. Accessed December 6, 2023. https://www.biospace.com/article/releases/bio-thera-solutions-announces-positive-results-from-phase-3-study-of-bat2206-a-proposed-biosimilar-referencing-stelara-/.
2. Stelara (ustekinumab) FDA approval history. Drugs.com. Accessed December 6, 2023. https://www.drugs.com/history/stelara.html.
3. Campbell P. FDA approves interchangeable biosimilar to ustekinumab. HCP Live. October 31, 2023. Accessed December 6, 2023. https://www.hcplive.com/view/fda-approves-interchangeable-biosimilar-to-ustekinumab.